Greater Toronto Area, Canada
Alex is a strong Business Operations and Research and development leader with extensive program management experience, and demonstrated ability in creating agile, high-performing engineering teams. Alex has a strong track record of success in the medical devices, medical robotics, defense, and aerospace industries and extensive experience in Product Development; Operations Management, Continuous Improvement, and quality, with assignments in the US, Canada, Middle East and China. He has a Mechanical Engineering degree and Master’s degree in Management Science from the University of Waterloo. Alex is experienced in directing R&D programs for technology and product development which have led to multiple patent filings, regulatory approvals, and commercialization of numerous medical products. - Sustained track record of planning, executing, and delivering R&D projects and programs to enterprise customers - Passionate about building diverse, high performing teams who engineer industry-leading products - Energized by fast-paced, dynamic environments - Proficient at leading start-ups and established companies through phases of rapid growth - Career-long change agent, devoted to inspiring continuous improvement Core Competencies: R&D: - Product Development - Team Development - Strategic Planning -- Technical report/documentation -- Medical device development -- Robotics - Program | Project Management - SR&ED applications - Agile Development - Risk Management -- ISO 9001 -- ISO 13485. Operations: - Operations management - Process improvement - LEAN/WCM/5S - Regulatory compliance
Drive initiatives to increase manufacturing capacity, including process optimization and in-house subassembly. Manage the service team that is responsible for resolution of critical product issues and all field service requests Lead development and validation processes of pharmaceutical solution used in EX-VIVO organ perfusion, including packaging validation, and regulatory submissions to meet compliance standards. Drive supply chain improvements by implementing ERP systems, establishing offshore sourcing, and reducing costs. Coordinate PMA submissions, focusing on key validations and biocompatibility milestones.
Responsible for strategic program direction and execution including the program planning effort, program risk management, program health reviews, and program change management. • Developing strategic program plans, program management plans, program charters and product roadmaps. • Spearhead project recovery assignments for challenged projects. • Conducting project health assessments and make recommendations to the PMO. • Working closely with clients, team members, and vendors to ensure that schedules are met and budgets are controlled. • Interfacing with Business Development to support the transfer of new activities into Engineering • Initiating and leading appropriate design reviews as required • Overseeing the work of team members to ensure compliance with regulatory standards, company procedures, product requirements, and specifications. • Ensuring that all required design and quality documentation is completed and all design processes are followed.
▪ Directly responsible for the overall operations in both Canadian and off-shore locations. ▪ Leading cross-functional team comprised of 25 professionals in engineering, quality, and operations. ▪ Implemented WCP (World-Class-Manufacturing), LEAN/5S manufacturing throughout the company, ▪ Designed production cells to support new product lines; including process development and mapping, cell layout, and purchasing new equipment. ▪ Integrated a company-wide Key Performance Indicators (KPI’s) system to drive the company’s success at reaching targets. ▪ Defined and implemented the MRP system to support supply chain and production planning activities.
▪ Ensuring that all development objectives are met by hiring, training and coaching 10 engineers, scientists and technicians; the overall program budget of $10 million and more than $1.5 million in salary and operating expenses. ▪ Prepared and submitted multiple SR&ED and HTX claims to result in $800K - $1.1M annual returns. ▪ Implemented AGILE software development methodology that resulted in more than 40% improvement in program deliverables timelines and better adapting of design to changing requirements and business needs. ▪ Implemented Knowledge Management methodology that resulted in more than 25% reduction in development time and saving of 20-30 man-hours per week by an elimination of unnecessary technical meetings. ▪ Facilitated product certifications required per FDA, IEC/UL (CSA) and CE regulations.
▪ Provided operating performance oversight and leadership to 3 production centers in 3 countries with more than 250 employees and $30 million in salary and operating expenses. ▪ Performed large-scale mass production operations analyses that resulted in production costs saving of more than $50,000. ▪ Integrated cells automation and supply chain upgrades, improved an annual profit margin by more than $120,000 per year. ▪ Played a key role in establishing off-shore manufacturing capacity and provided operating performance oversight and leadership to 3 manufacturing centers in 2 offshore countries with more than 100 employees and $10 million operations. ▪ Prepared and led multiple DFMEA and PFMEA resulting in throughput yield (TPY) improvements from 60% to 95% (for multiple product lines) and full in-process detectability of defects.